Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company
leveraging its proprietary DNAbilize® antisense RNAi nanoparticle
technology to develop a portfolio of targeted nucleic acid cancer
drugs, announced that data from pre-clinical studies supporting the
potential of BP1003, a novel liposome-incorporated STAT3
oligodeoxynucleotide inhibitor, for the treatment of pancreatic
cancer, non-small cell lung cancer (NSCLC) and acute myelogenous
leukemia (AML) were presented in a poster at the American
Association for Cancer Research (AACR) Annual Meeting 2019 today in
Atlanta, GA.
The poster, entitled “BP1003, a Novel Liposome-Incorporated
STAT3 Antisense Oligodeoxynucleotide Inhibitor,” was presented by
Ana Tari Ashizawa, Ph.D., Vice President of Research and
Development at Bio-Path.
The poster highlights four antisense oligo sequences directed
against STAT3 mRNA identified by Bio-Path and manufactured using
DNAbilize® antisense RNAi nanoparticle technology. Cell
viability tests and Western blots were conducted to determine the
inhibitory effects of liposome-incorporated STAT3 antisense oligo
on NSCLC and AML cells. An ex vivo live tissue sensitivity assay
(LTSA) was performed with a panel of 20 pancreatic ductal
adenocarcinoma (PDAC) patient-derived xenografts (PDX) to study the
overall activity of BP1003 alone, and in combination with
gemcitabine. Using previously defined criteria, tissue slice
viability inhibition greater than 30% and with a p<0.05 was
considered to be a response. For validation of ex vivo results,
PDAC PDX tumor bearing mice were administered BP1003 and
gemcitabine twice a week for 28 days. Tumor volumes were monitored
for up to 49 days.
The most potent liposome-incorporated STAT3 antisense sequence
in decreasing NSCLC cell viability was selected as the drug
candidate BP1003. Further validation in AML cells demonstrated that
BP1003 inhibited cell viability and STAT3 protein expression. In
the ex vivo LTSA assay, BP1003 at a dose of 10 µM significantly
inhibited the tissue slice viability in 9 out of 18 PDAC PDXs by
more than 30% (p<0.05). The combination of BP1003 and
gemcitabine further enhanced ex vivo efficacy of BP1003 in a subset
of PDXs. In the in vivo study with PDAC PDX models, a combination
of BP1003 and gemcitabine caused tumor regression during the 28-day
drug treatment period. This anti-cancer activity was maintained for
another 21 days, even when drug treatment had ceased.
Preclinical pancreatic cancer models demonstrated that BP1003
successfully penetrated the stroma into pancreatic tumors. As
previously reported, Bio-Path’s lead drug candidate, prexigebersen,
has been tested in the above-described ex vivo pancreatic cancer
preclinical model, and the results also demonstrated that
prexigebersen penetrated the pancreatic tumors. Finally, the
results in pancreatic cancer showed that BP1003 inhibited tumor
slice viability in 9 of 18 PDAC PDXs.
“We believe these data suggest that between our two drug
candidates, BP1003 and prexigebersen, Bio-Path will be able to
treat human pancreatic tumors. The Company expects to
initiate a Phase I study of prexigebersen for the treatment of
solid tumors in 2019, including a cohort of metastatic pancreatic
cancer patients. We plan to complete Investigational New Drug (IND)
enabling studies in 2019 and to file an IND application for a Phase
I study of BP1003 for the treatment of pancreatic cancer in 2020,”
stated Peter Nielsen, Chief Executive Officer of
Bio-Path.
“We developed BP1003, a novel liposome-incorporated STAT3
antisense oligodeoxynucleotide, as a specific inhibitor of STAT3 as
it is thought to be one of the most important genes involved with a
variety of cancers. STAT3 is considered to be an undruggable
target, which has hampered the development of a therapy for
it. Inhibition of STAT3 requires a systemic RNAi solution,
such as DNAbilize, in order to exert its anti-cancer activity,”
noted Dr. Tari Ashizawa.
“These data are very encouraging and suggest that our two drug
candidates, BP1003 and prexigebersen, are active against pancreatic
cancer which is often treatment refractory and lethal. As
with prexigebersen, studies to date have shown BP1003 to be
generally safe and well-tolerated in preclinical models. We believe
there is a great potential for the additional development of BP1003
as a treatment for NSCLC, AML and a variety of metastatic cancers,”
added Mr. Nielsen.
About Signal Transducer and Activator of Transcription 3
(STAT3)
Signal Transduction and Activator of Transcription-3 (STAT3),
though typically inactive in normal cells, is aberrantly active in
cancer cells. The abilities of tumor cells to proliferate
uncontrollably, resist apoptosis, induce vasculature formation, and
invade distant organs are well-recognized hallmarks of cancer.
STAT3 is a regulator of the genes involved in these cancer
processes. More recently, the capability of tumors to evade
immune surveillance and avoid destruction by the immune system has
also gained significant acceptance in the cancer research
field. STAT3, which is a point of convergence for many
oncogenic pathways, has emerged as a critical mediator of tumor
immune evasion at multiple levels.
Activation of STAT3 has been found in many types of cancers,
including NSCLC, AML, and PDAC. Activation of STAT3 correlates with
poor clinical outcome, high grade disease and metastasis, and has
been linked with resistance to chemotherapy, including gemcitabine,
considered a standard-of-care agent for advanced PDAC. Therefore,
inhibition of STAT3 in combination with chemotherapy is expected to
produce enhanced clinical benefit.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a
novel technology that has yielded a pipeline of RNAi
nanoparticle drugs that can be administered with a
simple intravenous transfusion. Bio-Path’s lead product
candidate, prexigebersen (BP1001, targeting the Grb2 protein), is
in a Phase 2 study for the treatment of blood cancers and in
preclinical studies for solid tumors. The Company is also
developing BP1002, which targets the Bcl-2 protein and is expected
to be evaluated for the treatment of lymphoma and solid tumors. In
addition, BP1003, a novel liposome-incorporated STAT3 antisense
oligodeoxynucleotide developed by Bio-Path as a specific inhibitor
of STAT3, is expected to enter Phase 1 studies in 2020.
For more information, please visit the Company's website at
http://www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws. These statements are based on management's current
expectations and accordingly are subject to uncertainty and changes
in circumstances. Any express or implied statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. Any statements that are
not historical facts contained in this release are forward-looking
statements that involve risks and uncertainties, including
Bio-Path’s ability to raise needed additional capital on a timely
basis in order for it to continue its operations, Bio-Path's
ability to have success in the clinical development of its
technologies, the timing of enrollment and release of data in such
clinical studies and the accuracy of such data, limited patient
populations of early stage clinical studies and the possibility
that results from later stage clinical trials with much larger
patient populations may not be consistent with earlier stage
clinical trials, the maintenance of intellectual property rights,
risks relating to maintaining Bio-Path's listing on the Nasdaq
Capital Market and such other risks which are identified in
Bio-Path's most recent Annual Report on Form 10- K, in any
subsequent quarterly reports on Form 10-Q and in other reports that
Bio-Path files with the Securities and Exchange Commission from
time to time. These documents are available on request from
Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact Information:
Investors
Will O’ConnorStern Investor Relations,
Inc.212-362-1200will@sternir.com
Doug MorrisInvestor RelationsBio-Path Holdings,
Inc.832-742-1369
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